Year-end spending bill: what's in and what's out
Funding bill to reform accelerated approval, mandate clinical trial diversity plans, but leaves VALID Act on cutting room floor
Among the provisions that made it into the Consolidated Appropriations Act 2023 — which must be enacted by Friday to avert a government shutdown — are authorities and requirements meant to strengthen the accelerated approval pathway and a mandate for companies to create clinical trial diversity plans.
The legislation would require FDA to specify post-approval study requirements by a therapy’s approval date, and it explicitly states that the agency “may require” confirmatory studies to be under way at the time of approval. It would stop short of requiring all post-approval studies be under way at approval. ...